An Observational Post-Authorization Safety Surveillance (PASS) Study of Sycrest® (Asenapine) Among Patients Aged 18 and Older Diagnosed With Bipolar Disorder
Sponsor study identifier
Secondary identifiers
OTHER · Merck
observational
42
0 countries
N/A
Study Start
July 1, 2013
Actual (reported)Primary Completion
December 18, 2017
Actual (reported)Study Completion
December 18, 2017
Actual (reported)This study will assess asenapine (Sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (RISPERDAL®CONSTA®) and olanzapine (Zyprexa®). The occurrence of identified and potential clinically important risks will also be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 18, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2011
Actual (reported)December 20, 2011
Actual (reported)July 1, 2013
Actual (reported)December 18, 2017
Actual (reported)December 18, 2017
Actual (reported)Number of Participants with Bipolar Disorder with Identified and Potential Clinically Important Risks
Identified and potential clinically important risks will include: extrapyramidal symptoms, somnolence and sedation, neuroleptic malignant syndrome, rhabdomyolysis, seizure, hyperprolactinaemia, orthostatic hypotension, neutropenia, allergic reactions, dyslipidaemia and diabetes mellitus with the use of asenapine versus risperidone or olanzapine
Approximately 1 year
Number of Participants with Schizophrenia with Identified and Potential Clinically Important Risks
Approximately 1 year
Number of Participants without Diagnoses of Schizophrenia or Bipolar Disorder with Identified and Potential Clinically Important Risks
Approximately 1 year
Participants prescribed asenapine
Participants prescribed risperidone
Participants prescribed olanzapine
Participants with Bipolar Disorder codes who are included in the United Kingdom Clinical Practice Research Datalink (CPRD) and, if required, The Health Improvement Network (THIN) database. If pre-specified sample size and exposure criteria are met, secondary objectives will be conducted in 2 separate study populations: 1. Participants treated with asenapine and diagnosed with schizophrenia and no prior and/or concomitant diagnosis of bipolar disorder; 2. Participants treated with asenapine with no prior and/or concomitant diagnoses of bipolar disorder or schizophrenia, but diagnosed with i) Alzheimer's disease, ii) other diagnoses - mental disorders or iii) no diagnosis.
Medical Director
Merck Sharp & Dohme LLC
42 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2011
First Posted
December 20, 2011
Study Start
July 1, 2013
Actual (reported)Emotions in Schizophrenia and Bipolar Disorders: a Common Vulnerability?
Contact the study team to confirm eligibility.
Primary Completion
December 18, 2017
Actual (reported)Study Completion
December 18, 2017
Actual (reported)Last Updated
February 4, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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